1. Field of Invention
This invention relates to universal electronic data monitoring including their collection, wire or wireless transmission, computer analysis, detection and the classification of abnormalities in the data, where such abnormalities result in automatic alarms that are transmitted to recipients locally or world wide, thereby providing a basis for taking corrective action at the source of the data.
2. Discussion of Prior Art
Methods Using Hard Wired Transmission:
The prior art U.S. Pat. No. 4,583,524 to Hutchins (1986) shows a instructional system for reviving the victim of a heart attach. U.S. Pat. No. 5,199,439 to Zimmerman et al. (1993) shows the use of a quality control chart for direct and simple monitoring of data. However, the chart is used in a way that is not statistically valid. The reason is as follows. Statistical quality control charts assume that the data on which they are based are independent. That is, each measurement is completely unrelated to all previous measurements. In reality, the measurements are serially related. This is known as autocorrelation. None of these patents employs correlation as part of its analysis. Since correlation analysis is at least one of the requirements to make the charts valid, no valid conclusions can be drawn from the charts that use these patents.
U.S. Pat. No. 4,545,388 to John (1985), U.S. Pat. No. 4,519,395 to Hrushesky (1985), U.S. Pat. No. 4,844,086 to Duffy (1989), U.S. Pat. No. 5,215,098 to Steinhaus et al. (1993), and U.S. Pat. No. 5,564,433 to Thornton (1996) employ relatively static measures of correlation, but do not apply them to the dynamic creation of a valid quality control chart.
U.S. Pat. No. 5,941,820 to Zimmerman (1999), employs correlation. However, correlation is limited to autocorrelation in a single variable. It does not employ cross correlation analysis to incorporate the effects of other related variables. Also, it does not split the data into separate correlated and uncorrelated components of the data. Instead, autocorrelation is used to modify control chart limits, such that different control limits exist on a single chart. This is done in an attempt to create control limits which are more appropriate. Varying limits, all existing on the same chart, make the chart far more complicated, very difficult to read and very confusing. This patent shows software that to function, requires an expensive and dedicated medical prescription sensor/monitor, currently used in hospitals.
U.S. Pat. No. 5,505,199 to Kim requires a combination of pulse oximeter, motion detector, and video camera connected to a central unit, making it cost prohibitive for most home users. U.S. Pat. No. 5,490,523 to Isaacson et al. (1996) uses a pulse oximeter with built in readout but no alarm feature. U.S. Pat. No. 6,011,477 to Teodorescu, et al. (2000) does not affix any biomedical sensors to the human body and does not measure any actual internal biomedical vital signs. Any external motion detector is likely to alarm when it is too late to take corrective action.
None of these patents employs wireless transmission of data. Data sensors must be physically attached to a human being and hard wired to some other device. This limits the mobility of the person being monitored. Movement can cause wires to come loose. Wires can also be hazardous, especially to babies.
Methods Using Wireless Transmission:
U.S. Pat. No. 6,047,201 to Jackson (2000), uses a battery operated sensor (pulse oximeter) to collect data from a human baby, and transmits the data via the 900 MHz band to a battery operated monitor. The radio frequency operation prohibits its use in hospitals. Transmission in the 900 MHz band is very demanding on the battery. The sensor must be removed from the baby, periodically, to recharge the battery. Because of the charger port, the sensor cannot be sealed for water proofing. The monitor must also be recharged. Therefore, continuous monitoring is not possible for any appreciable length of time. The patent shows 8 hours. A baby can fall asleep anytime without notice. If the baby falls asleep while the sensor is being charged, there will be no data collection and therefore no monitoring. In any case the patent is limited to babies that are asleep. However, a baby can experience respiratory and/or cardiac difficulties while awake. The patent shows a 900 MHz band transmitting antenna as a wire with no constructed ground plane. In the 900 MHz frequency band, a wire antenna, or any other antenna without a ground plane, de-tunes when it is in proximity to the human body which also acts as an antenna. The receiving antenna is subject to the same defect. De-tuning means that the transmission frequency varies. Therefore, the signal is either altered so that the monitor receives incorrect and dangerously misleading values, or it becomes lost altogether between the transmitter and the receiver in the monitor. The user cannot change the transmission frequency to avoid interference from other devices transmitting at the same frequency. The monitor is limited to oxygen data, and shows only one oxygen measurement at a time. If the measurement drops below a predetermined level it sounds an alarm. There is no alarm for the case when a biomedical vital sign goes above a predetermined level. This patent is limited to monitoring a single vital sign in actual units. There is no alarm for the case when there is a sudden change in the vital sign. This patent does not employ autocorrelation or cross correlation and does not use a quality control chart. Therefore, there is no way to get a picture, pattern or any other sense of how the data is developing over time. U.S. Pat. No. 5,549,113 to Halleck, et al. (1996) shares similar features and shortcomings. It promises a transmission range of only 90 feet, which after accounting for adverse prevailing conditions (interference, metal sidings and walls containing electrical wires, etc.), is limited to just the room where the sensor is located. Continuous transmission at the frequency shown is not permitted by the FCC. Transmission is only intermittent. Therefore, there is no continuous monitoring.
Additional Shortcomings of the Prior Art.
In addition to the shortcomings listed above for each of the two sets of monitors, the following are shortcomings common to both. They all require expensive prescription sensor/monitors. None of them does multivariate data analysis designed to collectively support diagnosis, decision making and corrective action. None of them cross correlates two or more related variables. Therefore, only one variable at a time is monitored. None of them decomposes the data and displays them on common cause charts of internal systematically related effects and special cause charts of external random unrelated effects. None of them provides long duration independent sensors that can be connected to a monitor either by wire or wireless means. Either the battery has to be replaced or the sensor has to be removed and recharged during the time when it is required to be in operation. None of them provides universal ability to read data formats from different sources containing various combinations of variables. They all provide a limited alarm function. None of them provides graduated progressive sound, color, print and world wide, fax, email and telephone alarm signals when the chart values exceed predetermined or user specified limits, either in terms of actual units or standard deviations, or when any particular pattern occurs.
The patents closest to the present invention are U.S. Pat. No. 5,941,820 to Zimmerman et al. (1999) and U.S. Pat. No. 6,047,201 to Jackson (2000). U.S. Pat. No. 5,941,820 to Zimmerman et al. (1999) shows charting, albeit a single chart only. However, it shows no wireless means or graduated alarms. U.S. Pat. No. 6,047,201 to Jackson (2000) shows wireless means of transmission, albeit of short duration only. However, it shows no charts and no graduated alarms. The present invention shows hard wired and wireless means of transmission, multiple variables—each with dual charts, and a system of graduated multiple alarm types.